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A Phase II Study of DMP 115 to Assess Focal Liver Lesions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00162058
First Posted: September 13, 2005
Last Update Posted: August 18, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Lantheus Medical Imaging
  Purpose
To determine the optimal dose of DMP 115 to image liver lesions and to assess whether contrast can improve the detection of focal liver lesions.

Condition Intervention Phase
Liver Disease Drug: Peflutren Lipid Microsphere Injectable Suspension Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: An Open-Label, Non-Randomized, Phase II Trial To Assess Focal Liver Lesion Detection Using Definity-Enhanced Ultrasound Imaging

Further study details as provided by Lantheus Medical Imaging:

Primary Outcome Measures:
  • The ratio of signal intensities obtained from unenhanced vs. contrast-enhanced ultrasound imaging of liver tissue and liver lesions will be calculated at the end of the study.

Secondary Outcome Measures:
  • The determination of the presence or absence of focal liver lesions during the Blinded Read and the Institutional Read of ultrasound images.

Estimated Enrollment: 80
Study Start Date: March 2004
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with 1 but <7 focal liver lesions
  • Scheduled for liver biopsy within 30 days of study
  • Scheduled for CT or MR within 30 days of study

Exclusion Criteria:

  • Critically ill subjects
  • Subjects with right-to-left shunts
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00162058


Locations
United Kingdom
Local Institution
Glasgow, Scotland, United Kingdom
Sponsors and Collaborators
Lantheus Medical Imaging
Investigators
Principal Investigator: Edward L.S. Leen, MD Consultant Radiologist, Royal Infirmary
  More Information

Responsible Party: Qi Zhu, MD Sr. Medical Director, Lantheus Medical Imaging
ClinicalTrials.gov Identifier: NCT00162058     History of Changes
Other Study ID Numbers: DMP 115-214
First Submitted: September 9, 2005
First Posted: September 13, 2005
Last Update Posted: August 18, 2011
Last Verified: August 2011

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases